In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings
MEMORANDUM OPINION AND ORDER
This multidistrict litigation proceeding (MDL) involves lawsuits by over 2,500 plaintiffs who allege that they have suffered injuries caused by defendants’ testosterone replacement therapy (TRT) drugs. The Judicial Panel on Multidistrict Litigation consolidated the cases before this Court for pretrial proceedings. Eight defendants— Actavis, Inc., Actavis Phar-ma, Inc., Actavis Laboratories UT, Inc., Watson, Laboratories, Inc. (the Actavis de
Background
The Food, Drug, and Cosmetic Act (FDCA)'requires drug manufacturers to gain approval from the United States Food and Drug Administration (FDA) before introducing a drug into interstate commerce.
An RLD is a previously approved drug ‘identified by FDA as the drug product upon which an applicant relies in seeking approval of ,its [ANDA]/
For purposes of this motion, the Court accepts as true the facts plaintiffs' have alleged jointly in their master complaint. The Court also takes judicial notice of the following publicly available facts with which both parties agree. The Pfizer defendants’ and Auxilium’s generic TRT drugs (Depo-Testosterone and Testopel, respectively) were approved through the ANDA process. Though they are ‘generic* in the sense ¡that neither was the pioneer drug, both drugs are marketed and sold under their branded names. In addition, FDA has designated both drugs as
The FDA has approved TRT products for the treatment of hypogonadism, the diminished furictional activity of the gonads, which may involve the severely diminished production or nonproduction - of testosterone. According to plaintiffs, however, defendants -in this- MDL have marketed their TRT drugs (including Depo-Testosterone and- Testopel) for treatment of a condition referred to as ‘Low T,‘ which' is not a form of classical hypogonadism and for which, plaintiffs allege, TRT drugs confer little or no benefit. In addition, they allege that the. drugs cause serious cardiovascular -problems, for which defendants failed to provide adequate warnings and which resulted in injuries to plaintiffs.
Plaintiffs’ master complaint asserts ten primary state law claims for relief against all defendants: strict liability claims based on design defect and failure to warn, negligence, negligent misrepresentation, breach of implied warranty of merchantability, breach of express warranty, fraud, redhibition, consumer protection, and unjust enrichment. In addition to those .primary claims, the complaint also asserts ‘claims'
The ANDA defendants have filed a motion to dismiss all claims and for judgment on . the pleadings pursuant to
Discussion
' A Court applies' the same standard of review to motions under
A. Preemption
Through their briefing, the parties have distilled the preemption , issue down to a single question: whether federal law permits the ANDA defendants to unilaterally make changes to their TRT drugs’ warning labels.
Plaintiffs do not contend that the ANDA defendants are able to redesign or alter the composition of their ANDA drugs. They do, however, dispute the ANDA defendants’ contention that they cannot unilaterally change their drugs’ warnings. Plaintiffs argue that because the ANDA defendants may strengthen their warnings, and because all of plaintiffs’ claims ‘flow, to some extent* from the ANDA defendants’ alleged failure to provide adequate warnings, Pis.’ Resp. at 17, the ANDA defendants had a permissible avenue under federal law to escape state-law liability on each of plaintiffs’ claims. Thus they argue that under Wyeth v. Levine,
The Court agrees with the parties’ respective statements of preemption .. law. Plaintiffs do not deny that the ANDA defendants ar.e unable to redesign, their drugs under federal law, and they admit that all of their claims are premised on an alleged failure to warn. Thus the ANDA defendants are correct that under Bartlett and Mensing, if federal law prohibits them from unilaterally changing their warning labels, all of plaintiffs’ claims against them are preempted. Similarly, plaintiffs are correct that under Wyeth, plaintiffs’ claims survive if federal law allows a path for the ANDA defendants to change their labels independently. The Court thus turns to the pivotal question of whether any such path exists.
In Wyeth, the Supreme Court ruled that state-law failure-to-warn claims brought against the manufacturer of a brand-name
Two years after Wyeth, the Supreme Court confronted a similar set of facts in Mensing, a case in which manufacturers faced state-law claims based on their alleged failure to provide adequate, warning labels for their drug. Mensing,
On its face, the CBE regulation itself does not distinguish between generic and branded (or ANDA and NDA) drug manufacturers in allowing unilateral changes to strengthen drug labels. See
Under a straightforward application of Mensing, the staté-law claims against the ANDA holders in this case would also appear to be preempted. Plaintiffs argue,
In deferring to the FDA’s position that generic manufacturers could not make unilateral labeling changes through the CBE process without violating federal law, the Court in .Mensing cited the federal statutory and regulatory provisions that ‘require[d] a generic drug’s label to match its brand-name counterpart’s.' Id. at 2575. But, as plaintiffs explain, those provisions do not actually use the terms 'generic' or 'brand-name.' Instead, they only require the ANDA drug’s label to be the same as the RLD upon which its application is based. See, e.g.,
Every federal court to consider plaintiffs’ argument has rejected it. See, e.g., Darvocet,
In Reglan, the court concluded that the defendant RLD holder had failed to establish with ‘the requisite certainty* that modifying its label , was impossible. Id. The court noted that none of the generic manufacturers in Mensing were RLD holders, id. at 226, and — operating without ‘the benefit of the FDA’s interpretation of its own regulations' — it found no indication in the FDA’s regulations that ‘only brand-name manufacturers that obtained NDA approval, rather than RLDs generally, can utüize the [CBE] process.' Id, at 227. In reaching its conclusion, the court reasoned that if the CBE process were only available to NDA RLD holders, FDA would have no reason to designate a successor RLD once the original RLD withdraws its drug. Id. In such situations, ANDA applicants could continue to show in their applications that their drugs were equivalent to the original NDA RLD. Id. But, the court suggested, a successor RLD js necessary to ‘bear,. .responsibility for the content of the label [and] the continued safety and efficacy of the drug.' Id. When an ANDA drug is designated as the RLD, the court concluded, the manufacturer must be able to use the CBE process to exercise this responsibility.
As "defendants point out, however, the interpretation of FDA regulations offered by the court in Reglan is unper suasive in light of FDA’s own interpretation of the same regulations. As the Sixth Circuit concluded in Darvocet, FDA ‘made clear' in' a guidance issued in 2013 that the CBE process is not available to ANDA RLD holders.
Under existing FDA regulations, ANDA holders cannot make labeling changes through the formal supplement process under. 21 CFR 314.70 in all circumstances in which NDA holders can because an ANDA’s labeling must be the same as the NDA RLD’s labeling (with some exceptions, as described in 21 CFR 314.94(a)(8)(iv)). Accordingly the [CBE] supplement process under 21 CFR 314.70(c) is not expressly available to ANDA holders except to match the RLD labeling or' to respond to FDA’s specific request to submit a labeling change under this provision.
FDA, Center for Drug Evaluation and Research, Guidance for Industry: Safety Labeling Changes—Implementation of Section 505(o)(i) of the FD & G Act, at 7 n.10 (July 2013), available at http://www.fda. gov/downloads/Drugs/GuidanceCompliance Regulatorylnformation/Guidances/ UCM250783.pdf (last visited-Nov. 9, 2015). Plaintiffs argue that the- Sixth Circuit misinterpreted the guidance as providing that ANDA RLDs can never use the CBE process to make unilateral labeling changes. This interpretation, plaintiffs contend, ignores an important qualifying phrase: the provision says only that ANDA holders are unable to make labeling changes ‘in all circumstances in which NDA holders can.‘ Plaintiffs argue that FDA included
A later interpretation from the FDA reinforces the Sixth Circuit’s interpretation of the FDA guidance in Darvocet. In November 2013, the FDA issued an analysis of a proposed rule that would allow ANDA holder to make unilateral changes to their labels. In its analysis, the FDA expressly discussed the options available to ANDA RLD holders who believe their drugs’ labeling should be changed: ‘Currently, these ANDA holders must contact FDA if they believe that new safety information should be added to their product labeling unless a labeling change already has been requested by FDA.‘ FDA, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products: Preliminary Regulatory Impact Analysis, at 9, available at http:// www.fda.gov/downloads/AboutFDA/ ReportsManualsForms/Reports/Economic Analyses/UCM 375128.pdf (last visited Nov. 9, 2015). According to FDA, therefore, ANDA RLD holders have no more authority than other ANDA holders to change their labeling unilaterally through the CBE process.
With the benefit of FDA’s interpretation of its own regulations, which the court in Reglan lacked, this Court agrees with the Sixth Circuit in Darvocet and all the other federal courts to address this issue in concluding that RLD ANDA holders are prohibited under federal law from unilaterally changing their drugs’ warning labels. As defendants note in response to the court’s question in Reglan about the purpose of designating a successor RLD if the ANDA RLD holder could not use the CBE process: ‘Future ANDA applicants must have a drug against which to compare their active ingredient, route of administration, dosage form, strength, and bioequivalence, and to match them current label-ing____‘ Defs.’ Reply Br. at 8 (citing
Because, as. every other federal court has concluded, the ANDA defendants are prohibited from unilaterally altering their warning labels under federal law, plaintiffs’ staté-law claims that depend on those defendants’ failure to do so are preempted. See Mensing,
B. Discovery
Plaintiffs request discovery, prior to a ruling on this motion, in the hope that they might find evidence that the ANDA defendants actually made unilateral changes to their RLDs’ labels. Plaintiffs state they are aware of at least two instances where the previous RLD holder for Depo-Testos-terone made such changes to the Depo-Testosterone label. As plaintiffs concede, however, the preemption issue is ‘primarily a legal question.' Pis.’ Resp. at 21. ‘The
In addition, plaintiffs request discovery regarding the- possibility that the ANDA defendants knew or should have known of the need to change their labels before the enactment of laws in 1984 (the so-called Hatch-Waxman Amendments) that established the requirement that an ANDA drug’s label be identical to the drug listed in its application. Defendants respond that plaintiffs’ complaint-does not contain any allegations that -the ANDA defendants knew or should have known, of the need to change their labels prior to 1984. For this reason, the Court denies plaintiffs’ request for discovery. If plaintiffs believe they can, consistent with their obligations under
Conclusion
For the reasons stated above, the Court grants defendants’ motion to dismiss [dkt. no. 770] with regard to all claims involving defendants’ drugs that were approved pursuant to abbreviated new drug applications and denies plaintiffs’ request for discovery related to the preemption issue.
Notes
. The latter three counts are not actually independent tort claims.
. In addition to raising this preemption ques- ■ tion, defendants’ motion to dismiss also at
. The Court also rejected the possibility that manufacturers could escape state-law liability by sending additional warnings via ‘Dear Doctor' letters, deferring to FDA’s position that such letters qualify as ‘labeling' and so must be consistent with the labeling "FDA had already approved. Id. at 2576.
. See also Hogue v. Pfizer, Inc., No. 2:10-CV-805,